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Ketamine Therapy for PTSD (CONCHKAP Trial)

Phase 1 & 2

Waitlist Available

Led By Snehal Bhatt, MD

Research Sponsored by University of New Mexico

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Between the ages of 18 to 65 years old.

Be older than 18 years old

Must not have

Clinically significant physical exam findings or self-reported medical conditions for which a transient increase in blood pressure could be significantly detrimental (e.g. glaucoma, aneurysmal disease, cardiovascular disease, or end-stage renal disease).

Subjects who meet DSM-5 criteria for current bipolar disorder based on clinical interview.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28-35 days

Awards & highlights

No Placebo-Only Group

Summary

This trial will investigate how Ketamine Assisted Psychotherapy affects people with PTSD to see if it improves their symptoms and alters brain activity.

Who is the study for?

This trial is for adults aged 18-65 with PTSD who can consent and communicate in English. They must avoid alcohol, cannabis, and stimulants on session days, have stable psychotropic medication doses if applicable, not drive post-session, and have a support person available. Excluded are those at suicide risk, recent hospital visits, substance use disorders (except tobacco), pregnant/nursing women without birth control agreement, high blood pressure or heart issues, liver/renal dysfunction, bipolar or psychotic spectrum disorders history.

What is being tested?

The study examines Ketamine Assisted Psychotherapy's impact on PTSD symptoms and brain connectivity changes. Participants will undergo sessions where they receive ketamine hydrochloride while engaging in psychotherapy to determine its effectiveness in treating their condition.

What are the potential side effects?

Ketamine may cause side effects such as increased blood pressure during administration which is why individuals with cardiovascular conditions are excluded from the trial. Other potential side effects include dissociation (feeling disconnected from reality), nausea or vomiting.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a condition like glaucoma or heart disease where high blood pressure could be harmful.

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I have been diagnosed with bipolar disorder.

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I have high blood pressure with readings above 140/90 mmHg.

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I have significant liver or kidney problems.

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My blood pressure is 140/90 or lower on the day I get the study drug.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28-35 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28-35 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28-35 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinical outcome: PTSD severity

Imaging Outcome: Changes in functional connectivity

Secondary study objectives

Correlation of clinical and imaging outcomes

Depression severity

Persisting MDD effect

+1 more

Side effects data

From 2020 Phase 4 trial • 75 Patients • NCT03156504

Lightheadedness with low blood pressure

Pump Malfunction

PTSD

100%

80%

60%

40%

20%

Study treatment Arm

Ketamine

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Ketamine Assisted Psychotherapy [KAP]Experimental Treatment1 Intervention

A total of 14 adult patients with PTSD will be recruited from UNM outpatient clinics and undergo rsfMRI and behavioral assessment prior to ketamine treatment. They will complete baseline scan at day one, a preparatory session (initial part of KAP), IM ketamine treatment, then within 24 hours, an integration session to take advantage of neuroplasticity for optimal therapeutic progress. Each participant will have two complete KAP sessions (preparation, treatment, and integration) followed by rsfMRI within approximately 24 hours, and again approximately two weeks after the completion of the second KAP session. Patients will also have repeat clinical assessments after each treatment. Changes in PTSD symptoms will be correlated with changes in connectivity at each rsfMRI.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ketamine Hydrochloride

2018

Completed Phase 4

~1890

0 / 6Eligibility criteria met